Argen-X

Beleggen, aandelen kopen in België, informatie, koersen en analyses

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piddybull
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Re: Argen-X

Bericht door piddybull »

Video : 30 minuten.
Ik diende me wel in te schrijven en via link mailadres opent alles vlotjes.

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https://onlinexperiences.com/scripts/Server.nxp

Deze link werkt blijkbaar niet.
Via mijn Twitteraccount kan je eventueel meer.
Deze video is randinformatie !
Maar geeft sterk aan dat Argenx begaan is met de patiënten.
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Argenx : out in anticipation

The Argonauts were able to achieve the unthinkable.







Volg Beursig.com op Twitter en Facebook


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piddybull
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Re: Argen-X

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Bron :https://www.dispatchtribunal.com/2020/1 ... 00-00.html




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Argenx : out in anticipation

The Argonauts were able to achieve the unthinkable.

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piddybull
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Re: Argen-X

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De originele PB

argenx Presents Additional Efgartigimod Data from Global Phase 3 ADAPT Trial at the Myasthenia Gravis Foundation of America 2020 Scientific Session

Breda, the Netherlands / Ghent, Belgium

New data consistent with positive topline results showing rapid and clinically meaningful responses to efgartigimod and safety profile comparable to placebo.
Biologics License Application on track to be submitted to U.S. Food and Drug Administration by end of 2020
argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer, today announced the presentation of new data from the pivotal Phase 3 ADAPT trial evaluating efgartigimod for the treatment of patients with generalized myasthenia gravis (gMG).

The presentation took place on Saturday, October 3, 2020 at the Myasthenia Gravis Foundation of America (MGFA) 2020 Virtual Scientific Session. argenx previously reported positive topline results from ADAPT in May 2020.

“Myasthenia gravis can be a very debilitating and potentially life-threatening chronic disease in patients leading to impairments that affect a patient’s ability to complete normal daily activities, including walking, swallowing, chewing food, talking or breathing easily. Efgartigimod demonstrated in ADAPT that it is well-tolerated and that patients can experience clinically meaningful improvements in key measures of function and strength following treatment, including, in some, the achievement of minimal symptom expression. These exciting results suggest that efgartigimod as a new potential therapy for gMG patients could have a real impact on some of the daily limitations that patients face,” commented James F. Howard Jr., M.D., Professor of Neurology (Neuromuscular Disease), Medicine and Allied Health, Department of Neurology, The University of North Carolina at Chapel Hill School of Medicine and principal investigator for the ADAPT trial.

Highlights of New Data Presented at MGFA 2020 Virtual Scientific Session

Magnitude of response: Substantial proportion of efgartigimod-treated acetylcholine receptor-antibody positive (AChR-Ab+) patients showed benefit at increasing thresholds on the Myasthenia Gravis Activities of Daily Living (MG-ADL) and Quantitative Myasthenia Gravis (QMG) scores compared to placebo patients at week four (one week after first treatment cycle).

At least half of efgartigimod-treated patients showed a five-point or greater improvement on the MG-ADL score (55.6%) and a six-point or greater improvement on the QMG score (50.0%)
One third (33.9%) of efgartigimod-treated patients showed a nine-point or greater improvement on the QMG score compared to zero patients on placebo
Repeatability of response: Similar proportion of efgartigimod-treated AChR-Ab+ patients were MG-ADL responders in the first (67.7% efgartigimod versus 29.7% placebo) and second (70.6% efgartigimod versus 25.6% placebo) treatment cycles (p<0.0001 for both cycles)

In efgartigimod-treated patients, mean change from cycle baseline in total MG-ADL score at week four was 4.6 in cycle one and 5.1 in cycle two
78.5% (51/65) of efgartigimod-treated patients were MG-ADL responders across treatment cycles one and two
Clinical benefit in seronegative patients: Inclusion of QMG score in responder analysis showed further evidence of activity in patients where AChR antibodies were not detected (AChR-Ab-)

52.6% (10/19) of efgartigimod-treated patients were responders on the QMG score compared to 36.8% (7/19) of placebo patients
Post-hoc analysis showed that 47.4% (9/19) of efgartigimod-treated patients were responders on both the QMG and the MG-ADL scores compared to 21.1% (4/19) of placebo patients
Key pharmacodynamic parameters: Total IgG and pathogenic autoantibody levels were reduced in efgartigimod-treated AChR-Ab+ patients throughout observation period, supporting proposed mechanism of action

Mean maximum reductions at week four were 61.3% for total IgG and 57.6% for AChR-Ab
Reductions similar across IgG subtypes and in overall population (AChR-Ab+ and AChR-Ab-)
No reduction in albumin levels
Key Topline Data Previously Reported from ADAPT

Topline data from ADAPT were reported in May 2020. The trial met its primary endpoint showing 67.7% of efgartigimod-treated AChR-Ab+ gMG patients were responders on the MG-ADL score compared to 29.7% of placebo patients (p<0.0001). Responders were defined by having at least a 2-point change on the MG-ADL for at least four consecutive weeks. Efgartigimod was demonstrated to be well-tolerated with a safety profile that was comparable to placebo.

63.1% of AChR-Ab+ patients were responders to efgartigimod compared with 14.1% on placebo on the QMG score (p<0.0001); responder defined as having at least a three-point improvement for at least four consecutive weeks.
40.0% of efgartigimod-treated AChR-Ab+ patients achieved minimal symptom expression (MG-ADL scores of 0 (symptom free) or 1) as a result of one treatment cycle, compared to 11.1% treated with placebo (p<0.0001).
84.1% of patients who were MG-ADL responders (37/44) had an onset of effect within the first two weeks
In AChR-Ab+ patients who met the primary endpoint, the majority showed a sustained response, including 88.6% who achieved a response for at least six weeks, 56.8% for at least eight weeks and 34.1% for at least 12 weeks
“These new data on the magnitude and repeatability of response continue to support the potential of efgartigimod as a meaningful treatment for gMG patients. ADAPT was also a broad trial which included

patients with acetylcholine receptor antibodies present and those without. We were pleased to show in this presentation proof of activity in the antibody-negative patients who are often left out of clinical trials,” commented Wim Parys, M.D., Chief Medical Officer of argenx. “It is particularly gratifying to present these favorable new data at the MGFA Virtual Scientific Session, a scientific meeting solely focused on addressing unmet needs for people living with gMG. We look forward to submitting our Biologics License Application for efgartigimod to the U.S. Food and Drug Administration before the end of the year with the goal to have efgartigimod available to patients and physicians in 2021.”

Phase 3 ADAPT Trial

The Phase 3 ADAPT trial was a randomized, double-blind, placebo-controlled, multi-center, global trial evaluating the safety and efficacy of efgartigimod in patients with gMG. A total of 167 adult patients with gMG in North America, Europe and Japan enrolled in the trial and were treated. Patients were eligible to enroll in ADAPT regardless of antibody status, including patients with AChR antibodies (AChR-Ab+) and patients where AChR antibodies were not detected. Patients were randomized in a 1:1 ratio to receive efgartigimod or placebo for a total of 26 weeks. ADAPT was designed to enable an individualized treatment approach with an initial treatment cycle followed by a variable number of subsequent treatment cycles. The primary endpoint was the number of AChR-Ab+ patients who achieved a response on the MG-ADL score defined by at least a two-point improvement for four or more consecutive weeks.

About Efgartigimod

Efgartigimod is an investigational antibody fragment designed to reduce disease-causing immunoglobulin G (IgG) antibodies and block the IgG recycling process. Efgartigimod binds to the neonatal Fc receptor (FcRn), which is widely expressed throughout the body and plays a central role in rescuing IgG antibodies from degradation. Blocking FcRn reduces IgG antibody levels representing a logical potential therapeutic approach for several autoimmune diseases known to be driven by disease-causing IgG antibodies, including: myasthenia gravis (MG), a chronic disease that causes muscle weakness; pemphigus vulgaris (PV), a chronic disease characterized by severe blistering of the skin; immune thrombocytopenia (ITP), a chronic bruising and bleeding disease; and chronic inflammatory demyelinating polyneuropathy (CIDP), a neurological disease leading to impaired motor function.

About Myasthenia Gravis (MG)

MG is a rare and chronic autoimmune disease where IgG antibodies disrupt communication between nerves and muscles, causing debilitating and potentially life-threatening muscle weakness. More than 85% of people with MG progress to generalized MG (gMG) within 18 months, where muscles throughout the body may be affected, resulting in extreme fatigue and difficulties with facial expression, speech, swallowing, and mobility. In more life-threatening cases, MG can affect the muscles responsible for breathing. Patients with confirmed AChR antibodies account for 80-90% of the total gMG population. There are approximately 65,000 people in the United States and 20,000 people in Japan living with the disease.

About argenx

argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer. Partnering with leading academic researchers through its

Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx is evaluating efgartigimod in multiple serious autoimmune diseases, and cusatuzumab in hematological cancers in collaboration with Janssen. argenx is also advancing several earlier stage experimental medicines within its therapeutic franchises. argenx has offices in Belgium, the United States, and Japan.

For more information, visit www.argenx.com and follow us on LinkedIn at https://www.linkedin.com/company/argenx/.

https://www.argenx.com/sites/default/fi ... _Final.pdf
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Brotherhood schreef:
05 okt 2020 20:00
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De PDF die ik vannacht vond wel,die zette ik er nogmaals bij maar ik betwijfel of iedereen hem al tenminste opende gezien de erg lauwe reactie's.
Je hebt niet voldoende permissies om de bijlagen van dit bericht te bekijken.
Argenx : out in anticipation

The Argonauts were able to achieve the unthinkable.

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Re: Argen-X

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http://www.argenx.com/news/argenx-expan ... rtnerships

New partnerships with Chugai and the Clayton Foundation for Research provide access to innovative antibody engineering technologiesExtension of Halozyme collaboration supports long-term commitment to subcutaneous delivery options for patients

argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer, today announced the expansion of its technology capabilities in antibody engineering through new partnerships with Chugai and the Clayton Foundation. The Company is also broadening its collaboration with Halozyme to enable subcutaneous delivery for three additional current or future argenx product candidates. Through these partnerships, argenx gains access to innovative technologies to advance its differentiated pipeline and strengthen its position as a leader in immunology.

“Our Immunology Innovation Program, through which we partner with leading academic researchers, has been foundational in building our pipeline. In keeping with our commitment to expand and strengthen this program, we continue to make investments in our portfolio of antibody technologies. These new partnerships are a key part of the strategy to broaden our capabilities in antibody engineering in order to address new targets and develop first-in-class medicines for patients who need them,” commented Hans de Haard, Ph.D., Chief Scientific Officer of argenx. “Additionally, we announced the extension of our collaboration with Halozyme to secure our ability to offer subcutaneous delivery of current and future pipeline candidates. We are on a mission to improve the lives of people suffering from severe autoimmune diseases and cancer and believe that this long-term collaboration will allow us to reach the greatest number of patients.”

New Antibody Engineering Research Agreements

argenx has entered into two new research agreements to broaden its antibody engineering capabilities. Through these agreements, argenx can access world-class Fc engineering technologies to expand the therapeutic properties of future antibody candidates that emerge from its Immunology Innovation Program. The technologies will complement argenx’s current portfolio of Fc engineering technologies (NHANCE®, ABDEG™, POTELLIGENT®) and enable the Company to further differentiate and expand its pipeline of antibody candidates.

argenx and Chugai have entered into a research license and option agreement under which argenx may access Chugai’s SMART-Ig® (“Recycling Antibody” and part of “Sweeping Antibody” technology) and ACT-Ig® (Antibody half-life extending technology).argenx and the Clayton Foundation have entered into a non-exclusive research agreement under which argenx may access the Clayton Foundation’s proprietary DHS mutations to extend the serum half-life of therapeutic antibodies.

Expansion of Access to Halozyme’s ENHANZE® Technology

argenx and Halozyme are expanding the existing global collaboration and license agreement that was signed in February 2019. Under the newly announced expansion, argenx gained the ability to access Halozyme’s ENHANZE® drug delivery technology for three additional exclusive targets upon nomination bringing the total to six potential targets under the collaboration. To date, two targets have been nominated including the human neonatal Fc receptor FcRn and complement component C2.

ENHANZE® has demonstrated across five FDA-approved products the ability to remove traditional limitations on the volume of biologics that can be delivered subcutaneously, potentially shortening drug administration time, reducing healthcare practitioner time, and offering additional flexibility and convenience for patients.

For more information about innovation at argenx, please visit the Company’s website at www.argenx.com/innovation.

About argenx

argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx is translating immunology breakthroughs into a worldclass portfolio of novel antibody-based medicines in early and late stages of clinical development. argenx is evaluating efgartigimod in multiple serious autoimmune diseases, and cusatuzumab in hematological cancers in collaboration with Janssen. argenx is also advancing several earlier stage experimental medicines within its therapeutic franchises. argenx has offices in Belgium, the United States and Japan. For more information, visit www.argenx.com and follow us on LinkedIn at https://www.linkedin.com/company/argenx/.
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Re: Argen-X

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piddybull schreef:
05 okt 2020 22:25
Brotherhood schreef:
05 okt 2020 20:00
Was al gepost...
Was nog niet gepost.

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De PDF die ik vannacht vond wel,die zette ik er nogmaals bij maar ik betwijfel of iedereen hem al tenminste opende gezien de erg lauwe reactie's.
Was niet op u bedoeld , ik had iets gepost dat al gepost was :D
Heb het wat slecht verwoord .

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piddybull
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Re: Argen-X

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Toffe reactie.
Nu snap ik je ook.
Ik was op moment van je post vrij zeker dat er andere PB was en keek alles gisterenavond nog eens na.
De reactie van Gentse strop spreekt wel boekdelen.
Daar komt beslist snel vuurwerk van ;-)
Argenx : out in anticipation

The Argonauts were able to achieve the unthinkable.

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piddybull
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Re: Argen-X

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De Tijd
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Argenx : out in anticipation

The Argonauts were able to achieve the unthinkable.

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piddybull
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Re: Argen-X

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Even opzoeken leert dat CHUGAI een onderdeel is van de ROCHE groep !
Interessant ?


https://www.chugai-pharm.co.jp/english/

Schermafbeelding 2020-10-06 om 13.55.38.png



Strategic Alliance with Roche

New business model that implements managerial autonomy
In 2002 Chugai completed a strategic alliance with the global pharmaceutical company, Roche, making us a member of the Roche Group.
In October 2002, Chugai merged with Nippon Roche based on a strategic alliance agreement with Roche, one of the world’s leading pharmaceutical companies, and Roche acquired a majority of Chugai’s stock. Chugai became a member of the Roche Group.
Je hebt niet voldoende permissies om de bijlagen van dit bericht te bekijken.
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Argenx : out in anticipation

The Argonauts were able to achieve the unthinkable.


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